RecruitingNot ApplicableNCT06262113

A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1


Sponsor

Massachusetts General Hospital

Enrollment

294 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings. Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits (e.g. an annual physical, a well-child visit, etc.) scheduled with a primary care provider (PCP) are eligible to enroll in the study. To see if you might be eligible, fill out a prescreening survey here: https://redcap.link/mynfguide


Eligibility

Inclusion Criteria10

  • Currently lives in the United States (including Puerto Rico and other United States territories)
  • Has a clinical diagnosis of neurofibromatosis 1
  • Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network
  • Has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent
  • Speaks English or Spanish
  • Currently lives in the United States (including Puerto Rico and other United States territories)
  • Cares for a child (age <18 years) with a clinical diagnosis of neurofibromatosis 1
  • Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network
  • Their child has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent
  • Speaks English or Spanish

Exclusion Criteria2

  • Only one person per household may participate in the study
  • Unwilling or unable to give informed consent

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Interventions

OTHERLetters about NF1 Care (Content Type 1)

Participants will receive two letters about NF1 care, one for themselves and one for their primary care clinician, to read in advance of the patient's annual wellness visit

OTHERLetters about NF1 Care (Content Type 2)

Participants will receive two letters about NF1 care, one for themselves and one for their primary care clinician, to read in advance of the patient's annual wellness visit


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06262113


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